Obesity is a multifactorial disease which affects upwards of 25% of the adult population in the United States of America. It is estimated that in the U.S.A. between 34-50 million adults are obese, with at least 5 million of those adults receiving medical treatment for their obesity. The etiology of obesity can range from simple overeating to severe hormonal imbalance. However, the great majority of obesity is probably due to a complex relationship between the many factors that regulate energy intake and utilization.
Teleologically, obese individuals may be better prepared for survival in time of limited food supply because of their ability to utilize energy in a more efficient manner. However, given that there is almost an unlimited food supply in the U.S.A., this efficiency of energy utilization probably leads to obesity. Furthermore, obesity is associated with an increased risk of cardiovascular disease, an increased risk of Type II diabetes, an increased risk of coronary artery disease, and other chronic diseases. For example, it is believed that in the U.S.A. there are over 6 million diagnosed cases of obese Type II diabetes, with an estimated 4 million cases being undiagnosed.
Given the large obese population and the associated problems, the area of obesity research and product development for the management of obesity has been explored, yet the problem remains. U.S. Pat. No. 4,351,835 teaches a method for preventing body fat deposition in mammals by oral administration of a mixture of pyruvate and dihydroxyacetone (DHA).
Subsequent additional research with rats investigated the effect of pyruvate and DHA under normal dietary conditions. In that study, rats were fed either a controlled diet or an experimental diet in which part of the carbohydrates were replaced with a 1:1 mixture of pyruvate and DHA, which mixture constituted 15% of the total caloric intake. Rats which received the experimental diet gained less weight, and had greater rates of heat production and energy expenditure than rats receiving a control diet. The experimental diet reduced body fat content by 32% without any significant effect on either protein or water content.
Similarly, in another study, Type II diabetic humans were fed 56 grams of pyruvate and DHA in a 1:1 mixture for seven days, during which time period glucose tolerance and turnover were measured. Reductions in fasting blood glucose concentration and peak glucose concentration after a glucose tolerance test were observed.
Yet another study assessed the relative effectiveness of pyruvate and DHA. In that study, obese Zucker rats were-placed in one of four diet groups. One diet was a control and each of the other diets featured a semi-purified rat diet with only one of the following features: (a) 6% pyruvate, (b) 6% DHA, or (c) 6% pyruvate/DHA (1:1). A number of physiologic variables were measured. The conclusion of the study was that generally changes due to the addition of DHA or pyruvate/DHA to the diet were not as great as changes due to the addition of only pyruvate. In fact, often the changes due to the addition of DHA or pyruvate/DHA could either be attributed to feed restriction or to the pyruvate in combination.
Finally, U.S. Pat. No. 4,548,937 discloses a method for minimizing weight gain by adding pyruvate to the diet.
Based on the above studies, the experimental data indicated that pyruvate was an efficacious compound in altering metabolic variables in rats. Pyruvate, also known as pyruvic acid, is a common metabolite of the body.
A problem exists in administering effective dosages of pyruvate to humans in that heretofore the only ways to supply pyruvate have been in the form of a liquefied pyruvic acid or in the form of the mineral salts of pyruvate, for example via sodium, potassium or calcium salts. These salts are organoleptically poor, as is tolerance of these salts. Furthermore, in humans the amount of these salts required to obtain the proper dosage of pyruvate for maximal effect raises the electrolyte level of the recipient to 2-6 times the safe and adequate recommended level when given as a supplement to a typical diet. With respect to the liquid pyruvic acid, the liquid is very acidic and results in the body literally being burned. Attempting to solve the acidity problem through dilution results in the human body being unable to ingest acceptable levels of pyruvate.
It is thus apparent that the need exists for an improved method of administering pyruvate to humans. It is also apparent that the need exists for an improved method of synthesizing a hydrolyzable precursor for pyruvate, other than in the form of a pyruvate salt.